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Norethindrone - Generic Drug Details

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Norethindrone is the generic ingredient in twelve branded drugs marketed by Aurobindo Pharma Ltd, Glenmark Generics, Novast Labs Ltd, Lupin Ltd, Mayne Pharma, Janssen Pharms, Apil, Amneal Pharms, Novast Labs, Jai Pharma Ltd, Parke Davis, Duramed Res, and Barr, and is included in twenty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-six drug master file entries for norethindrone. Nineteen suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for Generic Name: norethindrone

Drug Master File Entries: see list26
Suppliers / Packaging: see list19
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Drug Prices:see low prices

Pharmacology for Ingredient: norethindrone

Ingredient-typeProgesterone Congeners
Drug ClassProgestin

Tentative approvals for NORETHINDRONE

Applicant Application No. Form Dosage

Clinical Trials for: norethindrone

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novast Labs Ltd
TABLET;ORAL-28202014-001Sep 13, 2013RXNo
Glenmark Generics
TABLET;ORAL-28091209-001Jul 21, 2010RXNo
Aurobindo Pharma Ltd
norethindrone acetate
TABLET;ORAL204236-001Jan 8, 2016RXNo
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